A Pilot Study: Evaluating the Anti-Cancer Effects of Carvedilol With TTFields and Standard of Care in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells

Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The purpose of this pilot study is to evaluate the addition of carvedilol with standard of care treatment to determine if it will improve progression-free survival in the front line setting in patients with glioblastoma multiforme (GBM). In addition, monitoring of circulating tumor cells (CTCs) by a real-time reverse transcriptase polymerase chain reaction (qRT-PCR) assay to correlate with the clinical findings.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects must have histologically or cytologically confirmed WHO Grade IV Glioblastoma

• Subjects must have not received previous chemotherapy or radiation therapy for GBM

• Subjects must have systolic blood pressure greater than or equal to 90 and heart rate \>59

• Subjects who are on beta-blockers for other etiologies may enroll on study and switch therapy to carvedilol if deemed medical appropriate per treating physician

Locations
United States
West Virginia
WVU Cancer Institute - Mary Babb Randolph Cancer Center
Morgantown
Time Frame
Start Date: 2020-09
Completion Date: 2022-06
Treatments
Experimental: Carvedilol + Standard Treatment
Subjects will receive carvedilol starting at 6.25 mg orally (PO) twice daily for 1-2 weeks and if tolerated will then be increased to 12.5 mg PO twice daily starting on day 1 of concurrent chemoradiotherapy and continue daily until the end of adjuvant cycle 6 of temozolomide and Tumor Treated Fields.
Sponsors
Leads: West Virginia University
Collaborators: NovoCure Ltd., West Virginia Clinical and Translational Science Institute

This content was sourced from clinicaltrials.gov